BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS ANTI-CCP

    MDR report key: 23390835 · Received October 27, 2025

    Report

    Report Number
    1823260-2025-04358
    Event Type
    Malfunction
    Date Received
    October 27, 2025
    Date of Event
    July 21, 2025
    Report Date
    December 18, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NHX
    UDI-DI
    04015630940370
    PMA / PMN Number
    K081338
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE E801 ANALYZER SERIAL NUMBER WAS (B)(6). SAMPLE MATERIAL WAS RECEIVED FOR INVESTIGATION AND TESTED ON AN E801 ANALYZER WITH ANTI-CCP REAGENT LOT NUMBER: 860040. THE RESULT WAS 233 U/ML. THE CUSTOMER'S RESULTS WERE REPRODUCED AT THE INVESTIGATION SITE. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    UPON FURTHER INVESTIGATION OF THE PATIENT SAMPLE, AN INTERFERENT AGAINST THE STREPTAVIDIN COMPONENT OF THE REAGENT WAS CONFIRMED. THIS INTERFERENCE IS COVERED IN PRODUCT LABELING: "IN RARE CASES, INTERFERENCE DUE TO EXTREMELY HIGH TITERS OF ANTIBODIES TO ANALYTE-SPECIFIC ANTIBODIES, STREPTAVIDIN OR RUTHENIUM CAN OCCUR. THESE EFFECTS ARE MINIMIZED BY SUITABLE TEST DESIGN." THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION OF QUESTIONABLE HIGH RESULTS NOT CORRESPONDING TO THE CLINICAL PICTURE FOR 1 PATIENT TESTED FOR ELECSYS ANTI-CCP (ANTI-CCP) ON A COBAS E 801 ANALYTICAL UNIT. ON (B)(6) 2025, THE RESULT FROM THE E801 ANALYZER WAS 217 U/ML. THIS SAMPLE WAS SENT TO AN EXTERNAL LABORATORY USING THE THERMO FISHER METHOD, AND THE RESULT WAS "IN THE REFERENCE RANGE." THE SPECIFIC RESULT WAS NOT PROVIDED. ON (B)(6) 2025, A NEW SAMPLE WAS OBTAINED, AND THE RESULT FROM THE E801 ANALYZER WAS 235 U/ML. ON (B)(6) 2025, THE REPEAT RESULT FROM THE E801 ANALYZER WAS 236 U/ML. THIS SAMPLE WAS SENT TO AN EXTERNAL LABORATORY USING THE THERMO FISHER METHOD, AND THE RESULT WAS 1 U/ML (REFERENCE RANGE 0 ¿ 10 U/ML).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2427871 ELECSYS ANTI-CCP ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP) NHX ROCHE DIAGNOSTICS 860040 04015630940370

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female